doi:10.1111/j.1365-2591.2010.01833.

The efficacy of pre-operative oral medication of

lornoxicam and diclofenac potassium on the
success of inferior alveolar nerve block in patients
with irreversible pulpitis: a double-blind,
randomised controlled clinical trial

N. Prasanna1, C. V. Subbarao 1
& J. L. Gutmann2
1
Department of Conservative Dentistry and Endodontics, Saveetha Dental College and Hospitals, Saveetha University, Chennai,
India; and 2Professor Emeritus, Baylor College of Dentistry, Texas A&M Health Science Center, Dallas, TX, USA

Abstract responses (negative or positive) were recorded. Access

Prasanna N, Subbarao CV, Gutmann JL. The efficacy of
preoperative oral medication of lornoxicam and diclofenac
potassium on the success of inferior alveolar nerve block in
patients with irreversible pulpitis: a double-blind, randomised
controlled clinical trial. International Endodontic Journal.
Aim To determine the effect of administration of pre-
operative lornoxicam (LNX) or diclofenac potassium
(DP) on the success of inferior alveolar nerve blocks
(IANB) in patients with irreversible pulpitis in a double-
blind randomised controlled trial.
Methodology One hundred and fourteen patients
with irreversible pulpitis of a mandibular posterior
tooth participated. Patients indicated their pain scores
on a Heft Parker visual analogue scale, after which
they were randomly divided into three groups (n = 38).
The subjects received identical capsules containing
8 mg LNX, 50 mg DP or cellulose powder (placebo,
PLAC), 1 h before administration of IANB with 2%
lidocaine containing 1 : 200 000 epinephrine. Lip
numbness was assessed after 15 min, following which
the teeth were tested with cold spray and their
cavities were then prepared and success of IANB was
defined as the absence of pain during access prepara-
tion and root canal instrumentation. The data were
analysed using chi-squared tests.
Results The percentages of teeth giving a negative
response to cold test were 42.8% (PLAC), 78.5% (LNX)
and 67.8% (DP), with no significant differences
amongst the groups (P > 0.05). The success rates for
the IANB in descending order were 71.4% (LNX),
53.5% (DP) and 28.5 (PLAC). A significant
(P < 0.001) difference was found between the LNX
and the PLAC groups only.
Conclusions Pre-operative administration of LNX
significantly improved the efficacy of IANB in patients
with irreversible pulpitis, whilst the effect of pre-
medication with DP was not significantly different from
the PLAC.
Keywords: diclofenac potassium, inferior alveolar
nerve block, irreversible pulpitis, local anaesthesia,
lornoxicam, nonsteroidal anti-inflammatory drugs.
Received 30 April 2010; accepted 30 October 2010

local anaesthesia for root canal treatment of mandi-

Introduction
Although the inferior alveolar nerve (IAN) block is the
most frequently used injection technique for achieving
Correspondence: Dr N. Prasanna, Plot 1500, 16th Main Road,
Anna Nagar West, Chennai, Tamil Nadu, India (Tel.:
+91 44 98847 54914; fax: +91 044 2616 3639;
e-mail: prasanna@totaldentalcare.org).
bular teeth, it does not always result in successful
pulpal anaesthesia. Clinical studies in endodontics have
found failure with the IAN block occurring between
44% and 81% of the time (Cohen et al. 1993, Nusstein
et al. 1998).
Various mechanisms have been hypothesized to
explain the failure of local anaesthetics, including
anatomical variations, such as cross-innervations and

ª 2010 International Endodontic Journal International Endodontic Journal 1

 Lornoxicam and diclofenac on anaesthetic success Prasanna et al.
accessory innervations from the lingual nerve, buccal
nerve, mylohyoid nerve or cervical plexus, decreased
local pH, tachyphylaxis of anaesthetic solutions and
activation of nociceptors, including tetrodotoxin and
capsaicin-sensitive transient receptor potential vanil-
loid type 1 (TRPV1) (Rood 1977, Chaudhary et al.
2001, Hargreaves & Keiser 2002). Interestingly, the
success rates of local anaesthesia were found to be
worse in patients with inflamed pulpal tissues (Aggar-
wal et al. 2009, 2010, Tortamano et al. 2009).
The high failure rate of local anaesthesia in symp-
tomatic teeth with irreversible pulpitis could be attrib-
utable to the prostaglandin-induced sensitization of
peripheral nociceptors (Henry & Hargreaves 2007).
The receptors expressed by the peripheral terminals of
nociceptors can detect chemical and physical stimuli.
This results in activation of various ion channels
expressed on peripheral terminals. Inflammatory
mediators such as prostaglandins produce their effects
by binding to these various protein receptors. Prosta-
glandins (PGs) up-regulate a variety of mechanisms
that might decrease the efficacy of local anaesthetics:
altering the kinetics of activity of the voltage-gated
sodium channels, resulting in increased depolarization;
activation of EG protein-coupled receptors namely P2
or EP3 receptors, which are expressed on trigeminal
sensory neurons (Vane & Botting 1998, Gould et al.
2004). There is an increase in prostaglandins in
inflamed pulps (Reuben & Duprat 1996, Hargreaves
& Keiser 2002), and activation of nociceptors by PGs is
a major cause of increased incidence of failure of
inferior alveolar nerve blocks (IANB) in patients with
irreversible pulpitis (Modaresi et al. 2006, Wells et al.
2007). Therefore, decreasing the amount of prosta-
glandins may increase the efficacy of local anaesthetics.
Clinicians prescribe nonsteroidal anti-inflammatory
drugs (NSAIDs) on a routine basis for a range of
mild-to-moderate pain (Mickel et al. 2006). NSAIDs
reversibly inhibit cyclooxygenase (prostaglandin endo-
peroxide synthase), the enzyme-mediating production
of prostaglandins (PGs) and thromboxane A2. Given
the ability of NSAIDs in reducing nociceptor activation
by decreasing the levels of inflammatory mediators
(Gokin et al. 2001), it has been hypothesized that pre-
medication with NSAIDs will influence the success rate
of local anaesthesia in patients with irreversible pulpi-
tis. One study concluded that acetaminophen with
codeine or ibuprofen improved the efficacy of IANB
(Modaresi et al. 2006), whilst another report showed
that neither ibuprofen nor ketorolac caused any
improvement (Aggarwal et al. 2010). A report by
2 International Endodontic Journal
Ianiro et al. (2007) concluded that acetaminophen or
a combination of acetaminophen and ibuprofen im-
proved the success of IANB for teeth with irreversible
pulpitis.
Lornoxicam (LNX) is a compound of the so-called
oxicam class of NSAIDs, acting in part through the
nonselective inhibition of cyclo-oxygenase-1 and -2 to
produce analgesic and antipyretic effects (Berg et al.
1999). It is generally prescribed for osteoarthritis,
rheumatoid arthritis, acute lumbar-sciatica pain and
for post-operative pain management. Various prepara-
tions are available, including 4 or 8 mg oral (standard
or quick release) or injection (intravenous or intra-
muscular) preparations. A systematic review concluded
that a single dose of 8 mg LNX offered a high level of
pain relief to patients with moderate to severe post-
operative dental pain (Hall et al. 2009). Diclofenac,
which is also a NSAID, is a benzene acetic acid
derivative used to treat the pain and swelling associated
with rheumatic disorders. It is available in two different
formulations, diclofenac potassium (DP) and diclofenac
sodium, with the sodium salt used more frequently. The
immediate-release potassium formulation might pro-
vide pain relief more quickly (Bakshi et al. 1992).
Both LNX and diclofenac sodium have demonstrated
wide-spread effectiveness in their use, primarily
through their nonselective inhibition of cyclo-oxygen-
ase. Furthermore, both are provided in an immediate-
release formulation; their impact on inflammation
would therefore be beneficial in those cases where an
accentuated inflammatory response, because of the
presence of an irreversible pulpitis, may have an impact
on the success of mandibular local anaesthesia. More-
over, they have a short half-life, which would make
them ideal for a single dosage prior to the management
of severe tooth pain, in addition to ameliorating post-
treatment pain (Bakshi et al. 1992, Berg et al. 1999,
Hall et al. 2009). Therefore, the purpose of this
prospective, randomized, double-blind study was to
compare the efficacy of oral pre-medication of LNX, DP
and a placebo (PLAC) medication on anaesthetic
efficacy of IANB with lidocaine with 1 : 200 000
epinephrine in patients with irreversible pulpitis. The
null hypothesis tested was that there is no significant
difference amongst the three groups.
Materials and methods
One hundred and fifty adult volunteer subjects, within
the age range of 21–40 years, who reported to the
dental emergency department, were assessed for
ª 2010 International Endodontic Journal
 Prasanna et al. Lornoxicam and diclofenac on anaesthetic success

Enrollment Assessed for eligibility (n = 150)

Excluded (n = 36)
• Non vital teeth (n = 10)
• Allergic to NSAIDs(n = 4)
• Patients with active peptic ulcer (n = 8)
• Patients who had taken NSAIDs 12 h
before the study (n = 12)
• Breast feeding (n = 2)

Randomized (n = 114 )

Allocated to intervention -
placebo (n = 38)
♦ Received allocated
intervention (n = 38)
Allocation
Allocated to intervention – Diclofenac
Allocated to intervention - potassium (n = 38)
Lornoxicam (n = 38) ♦ Received allocated intervention (n = 38)
♦ Received allocated intervention
(n = 38 )

Patients analysed for lip
numbness (n = 38)
Patients eliminated due to
lack of lip numbness (n = 0)
Lip numbness
Patients analysed for lip Patients analysed for lip numbness (n = 38)
numbness (n = 38)
Patients eliminated due to lack of lip
Patients eliminated due to lack numbness (n = 0)
of lip numbness (n = 0)

Analysis of success of cold

testing and IANB
Analysed (n = 38)
Analysed (n = 38) Analysed (n = 38)

Figure 1 Consort flowchart.

eligibility to participate in this clinical trial, which
spanned over a period of 4 months (Figure 1). The
sample size was determined after performing a pilot
study with 15 patients per groups. A power calculation
showed that a sample size of 114 subjects would detect
a 30% difference in the success rate of the two test
groups at a power of 80% (a type I error of 0.05 and b
type II error of 0.20). Ethical approval was sought from
the Institutional Review Board and Ethical committee
of the University. Informed written consent was
obtained from each subject. Pre-operative radiographs
were obtained.
The inclusion criteria were as following: healthy
patients (ASA I or II) experiencing pain in a mandib-
ular molar with prolonged response to cold testing
(lingering pain for more than 45 s) with Green Endo Ice
(1,1,1,2 tetrafluoroethane; Hygienic Corp, Akron, OH,
USA) and an electric pulp tester (Kerr, Analytic
Technology Corp, Redmond, WA, USA), teeth with
vital pulp, the absence of periapical radiolucency on
radiographs, except for a widened periodontal ligament
(not more than 0.75–1 mm) and patients with the
ability to understand the use of pain scales. The results
of the cold testing and electric pulp testing (EPT) were
used to establish a confirmatory diagnosis of irrevers-
ible pulpitis. Patient exclusion criteria included those
with known allergy, sensitivity or contraindications to
any opioid or nonopioid analgesics including aspirin or
NSAIDs; those with a history of active peptic ulcer
within the preceding 12 months, a history of bleeding
problems or anticoagulant use within the last month,
or a history of known or suspected drug abuse; those
had taken opioid, nonopioid analgesics, steroids,
antidepressants or sedatives within 12–24 h before
administration of the study drugs; and those who were
pregnant or breast feeding. Patients experiencing active

ª 2010 International Endodontic Journal International Endodontic Journal 3

 Lornoxicam and diclofenac on anaesthetic success Prasanna et al.

pain in more than one mandibular molar were also
excluded. Following application of the criteria, 36
patients were excluded from the study, resulting in the
enrolment of 114 subjects for this trial.
Before initiating the treatment, the patients were
asked to rate their pain on a Heft Parker visual
analogue scale (VAS) with 170-mm line marked with
various terms describing the levels of pain (Heft &
Parker 1984). The millimetre marks were removed
from the scale, and the scale was divided into four
categories: no pain corresponded to 0 mm; faint, weak
or mild pain corresponded to 1–54 mm; moderate to
severe pain corresponded to 55–114 mm; and strong,
intense, maximum possible pain corresponded to more
than 114 mm (Claffey et al. 2004).
A trained dental hygienist divided 114 empty cap-
sules of the same colour and size into three bottles:
LNX, DP and PLAC groups. LNX capsules were filled
with 8 mg of LNX, DP capsules were filled with 50 mg
DP and PLAC capsules were filled with cellulose
powder. The bottles were masked with an opaque label
and were randomly assigned a three digit alphanu-
meric value by the pharmacist. All the patients were
randomly divided into three groups of 38 patients each
and were given one capsule 1 h before the procedure.
Randomization of patients was achieved by simple
random sampling with a linear congruential generator
by a trained dental hygienist who was blinded to the
treatment procedures. Only the alphanumeric values
were recorded on the data sheets to blind the exper-
iment. After 1 h of oral administration of the capsules,
all patients received standard IANB injections using
1.8 mL of 2% lidocaine containing 1 : 200 000 epi-
nephrine (Xylocaine; AstraZeneca Pharmaceutical
Products, Wilmington, DE, USA). The solution was
injected by the same clinician (first author) using self-
aspirating syringes (Septodont, Saint-Maur-des-Fosses
Cedex, France) and 27-gauge long needles (Septoject,
Second, if the patient did not feel pain or sensitivity to
the cold spray, a rubber dam was placed and a standard
endodontic access cavity was begun with a bur under
water spray coolant. If the patient felt pain during
access, the outcome was recorded as a failure and
supplemental anaesthesia was administered. Success of
IANB was defined as no pain during endodontic access
preparation and root canal instrumentation.
The data were recorded on a Microsoft Excel sheet
(Microsoft Office Excel 2003; Microsoft Corp, Redmond,
WA, USA) for statistical evaluation using a commercial
program (spss 19, Somers, NY, USA). The pre-medica-
tion codes were sent directly to the statistician by the
pharmacist. Age, initial and post-injection VAS scores
were tabulated and compared using multiple compar-
ison analysis of variance and post hoc tests. The gender
of the patients and type of tooth were compared by chi-
squared test. The significance level was set at P = 0.05
for these analyses. The proportions of successful IANB
in the LNX, DP and placebo groups were compared
using the chi-squared test.
Results
The age, gender, mean initial VAS scores and tooth type
were tabulated (Table 1). There were no significant
differences (P > 0.05) between the three groups. One
hundred per cent of the patients had subjective lip
anaesthesia with the IAN blocks. All patients reported a
significant decrease in active pain after local anaesthesia
(P < 0.05). The post-injection VAS scores are given in
Table 2. There was no significant difference between
Table 1 Comparison of age, gender and initial Heft Parker
visual analogue scale (VAS) scores amongst the three groups
Control Diclofenac
(Placebo) Lornoxicam potassium

Septodont, France). The solution was deposited at a Total number 38 38 38

rate of 1 mL min)1. of subjects
Age (Mean ± SD) 28 ± 7 26 ± 9 30 ± 6
After 15 min of the initial IANB, each patient was
(years)*
asked whether his or her lip was numb. If profound lip Gender*
numbness was not recorded within 15 min, the block Males 18 22 15
was considered unsuccessful and the patients were to Females 20 16 23
be excluded from the study. However, none of the Initial pain 98 ± 21 103 ± 26 101 ± 22
(Heft Parker
subjects were eliminated as a result of lack of lip
VAS)*
numbness. The tooth in question was tested again with Tooth*
cold spray (Green Endo Ice, Hygienic Corp, OH, USA), First molar 20 19 22
and two possible outcomes were recorded. First, if the Second molar 18 19 16
patient felt pain or sensitivity, the test was recorded as a *There were no significant differences between the three
failure and supplemental anaesthesia was provided. groups (P > 0.05).

4 International Endodontic Journal ª 2010 International Endodontic Journal


Table 2 Comparison of percentage of
successful cold test and inferior alveolar
nerve block amongst the three groups Treatment group
Control – Placebo
Lornoxicam
Diclofenac potassium
Mean values that share a superscript letter were not significantly different at the 5%
level.
LNX and DP in the post-injection VAS scores (P > 0.05),
whilst both LNX and DP resulted in significantly lower
mean VAS scores than PLAC (P < 0.05).
The number and percentage of patients with no
response to the cold test and successful IAN block (no
pain during access cavity preparation and canal
instrumentation) by the test, and control groups are
presented in Table 2. The percentage of patients with
negative response to cold test was as following: 42.8%
(16 of 38 patients) for the control PLAC groups; 67.8%
(26 of 38 patients) for pre-medication with DP; and
78.5% (30 of 38) for pre-medication with LNX. There
were no statistically significant differences amongst the
three groups. On the basis of absence of pain during
access and canal instrumentation, the percentage of
successful IAN blocks was as following: 28.5% (10 of
38 patients) in the control PLAC group, whilst pre-
medication with LNX and DP resulted in 71.4% (28 of
38 patients) and 53.5% (24 of 38 patients) successful
IANBs, respectively. The percentage of successful IAN-
Bs was significantly higher in the LNX group when
compared with the PLAC group (P < 0.001).
Discussion
The present study evaluated the efficacy of pre-medi-
cation with LNX or DP on the success of IANB. The
results of the present study demonstrate that the
success of IANB was significantly greater in patients
pre-medicated with LNX when compared to PLAC
(P < 0.001). There were no significant differences
between DP and LNX or PLAC (P > 0.05).
Two per cent lidocaine was chosen in this study
because several studies comparing lidocaine to other
anaesthetics including articaine, in the success of
pulpal anaesthesia found little or no significant differ-
ence in efficacy. Articaine (4%) with 1 : 100 000
epinephrine has been shown to be similar to 2%
lidocaine with 1 : 100 000 epinephrine in inferior
alveolar nerve blocks (Mikesell et al. 2005).
It is a commonly held belief that lip numbness implies
pulpal anaesthesia, yet in two clinical trials only 75%
ª 2010 International Endodontic Journal
Prasanna et al. Lornoxicam and diclofenac on anaesthetic success
Post-injection visual
Cold test IANB analogue scale scores
successful (%) successful (%) (Mean ± SD)
16 OF 38 (42.8) 10 OF 38 (28.5) 18 ± 2a
30 OF 38 (78.5) 28 OF 38 (71.4) 6 ± 3b
26 OF 38 (67.8) 24 OF 38 (53.5) 8 ± 3b
and 80% of the patients with lip numbness had pulpal
anaesthesia (Fuss et al. 1986, Petersson et al. 1999). In
the present study, 100% of the patients exhibited lip
numbness. Therefore, lip numbness may not be a good
indicator of pulpal anaesthesia, at least in inflamed
pulps. However, it was possible to draw a correlation
between success of cold test and IANB. These results are
comparable to previous reports (Ianiro et al. 2007).
Thus, cold testing may be considered more reliable than
lip signs to determine when to begin endodontic access
for patients with irreversible pulpitis. However, it is
important to note that negative response to cold testing
does not necessarily indicate a successful IANB.
The proposed mechanisms for the efficacy of LNX
include inhibition of conduction of C fibres (Sen et al.
2006), which are more resistant to local anaesthesia
than A-delta fibres. Also, opening of the K+ channels
located in the primary afferent nerve endings produces
antinociception and represents an important step in the
peripheral antinociceptive effect of several NSAIDs.
Activation of the NO–cyclic guanosine mono phosphate
(GMP) pathway could also induce antinociception
through the opening of K2+ channels. Such a mecha-
nism has been implicated for the antinociceptive action
of rofecoxib (Deciga-Campos & Lopez Munoz 2004). It is
possible that LNX produces a peripheral analgesic effect
via the same mechanism and thereby increase the
success rate of IANB.
Transient receptor potential vanilloid channels have
been implicated in pain signalling and thermo recep-
tion. TRPV1 plays a major role in hyperalgesia and
allodynia and is expressed in both the parasympa-
thetic nervous system and central nervous system,
(Patwardhan et al. 2009). The TRPV1 channel is
sensitized by prostaglandins and other inflammatory
mediators, leading to a potentiation of currents
through the channel. This lowers the temperature
threshold for activating the channel. It is likely that
TRPV receptors might partially mediate the pain of
pulpal origin and thus explain the exaggerated
response of teeth with irreversible pulpitis to thermal
stimuli (Alessandri-Haber et al. 2006). The activation
International Endodontic Journal 5
 Lornoxicam and diclofenac on anaesthetic success Prasanna et al.
of TRPV4 channel does not occur by the action of a
single inflammatory mediator but rather through the
concerted action of multiple mediators (Simmons et al.
2004). The present study revealed that 78.5% of the
patients pre-medicated with LNX had a negative
response to cold testing after IANB in contrast to
67.8% of patients who were administered DP.
Although this difference was not statistically signifi-
cant, it is possible that this may be because of the
ability of LNX to inhibit TRPV channels more effec-
tively than diclofenac. Further research is, however,
required in this direction.
The degree and duration of the damage and
up-regulation occurring before the prostaglandins were
inhibited by the NSAIDs is also a factor in influencing
success of IANB (Simmons et al. 2004). Prostaglandins
are effectively blocked by LNX and DP, and they have a
relatively short half-life. From the results of the present
study, it may be speculated that LNX may be more
effective than DP in inhibition of PGs, though no specific
evidence exists in this regard. This also warrants further
inspection.
Conclusions
Oral pre-medication with 8 mg LNX but not 50 mg DP
resulted in significantly higher percentage of successful
inferior alveolar block in patients with irreversible
pulpitis than pre-medication with PLAC.
Acknowledgements
The authors wish to thank Dr Matthias Zehnder,
Universität Zürich for his valuable guidance in pre-
reviewing the manuscript.
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International Endodontic Journal 7